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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Suction, Tracheobronchial
510(k) Number K842166
Device Name INTERMED, INS STERILE WATER/SALINE
Applicant
INTERMED, INC.
15 WHITE LAKE RD.
SPARTA,  NJ  07871
Applicant Contact NORMAN T RUEDT
Correspondent
INTERMED, INC.
15 WHITE LAKE RD.
SPARTA,  NJ  07871
Correspondent Contact NORMAN T RUEDT
Regulation Number868.6810
Classification Product Code
BSY  
Date Received05/31/1984
Decision Date 02/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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